Thailand medical device registration is managed by the Medical Device Control Division of the Thai Food and Drug Administration (FDA) according to the Medical Device Act B.E. 2551 (2008). While changes are scheduled for later in 2018 that will bring alignment with the ASEAN Medical Device Directive (AMDD), the current regulatory system requires medical devices to apply for and obtain a License, Notification, or Certification from the FDA prior to importation depending on classification.
1 YEAR PROCESSING TIME
6-8 MONTHS PROCESSING TIME
2 TO 6 DAYS PROCESSING TIME (TYPICAL)
515 Congress Avenue, Suite 2100
Austin, TX 78701